Novobiocin Sodium Intramammary Infusion
»Novobiocin Sodium Intramammary Infusion is a suspension of Novobiocin Sodium in a suitable vegetable oil vehicle.It contains suitable preservative and suspending agents.It contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of novobiocin (C31H36N2O11).
Packaging and storage— Preserve in disposable syringes that are well-closed containers.
Labeling— Label it to indicate that it is for veterinary use only.
Water,Method Iá921ñ: not more than 1.0%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Assay— Proceed as directed for novobiocin under Antibiotics—Microbial Assays á81ñ,expelling the contents of a syringe of Intramammary Infusion into a high-speed blender jar containing 1.0mLof polysorbate 80and 499.0mLof Buffer No.3,and blend for 3to 5minutes.Allow to stand for 10minutes,and dilute quantitatively and stepwise with Buffer No.6to obtain a Test Dilutionhaving a concentration of novobiocin assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1406
Phone Number:1-301-816-8178
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